Impedimed Limited · ASX:IPD
Impedimed — Non-Deal Roadshow (March 2009)
27 slides from Impedimed's roadshow presentation, Mar 30, 2009
Slide 1: ASX Release - Investor Presentation
ASX : IPD th 30 March 2009 For personal use only ASX RELEASE - INVESTOR PRESENTATION ImpediMed Limited wishes to advise that CEO Greg Brown is undertaking an investment roadshow visiting both Australian and US based institutional investors and will use the attached presentation to introduce the comp
Slide 2: ImpediMed Limited: Surviving cancer without compromising lifestyle
For personal use only ImpediMed Limited Surviving cancer without compromising lifestyle
Slide 3: Safe Harbor: Forward Looking Statements
Safe Harbor For personal use only Forward Looking Statements Certain sections of this presentation contain forward-looking statements which are based on management’s expectations, estimates, projections and assumptions. Words such as “expects,” “anticipates,” “plans,” “believes,” “scheduled,” “estim
Slide 4: Overview
Overview For personal use only Commercial company with recent FDA cleared & launched point of care diagnostic device for lymphedema Currently listed on the Australian Stock Exchange (fully diluted market k cap off ~US$40mm) S$ 0 ) Current shareholders include • Starfish Ventures • ORBIS • Macq
Slide 5: Investment Highlights
Investment Highlights For personal use only Lymphedema y p represents p a large g & underserved market Multi-hundred million dollar annual consumables market opportunity ImpediMed p has the first cleared technology gy to enable pre-emptive p p care Proven prevention of lymphedema progression
Slide 6: What is Lymphedema?
What is Lymphedema? For personal use only Lymphatics y p - circulatoryy system y for immunityy & removal of cellular waste Lymphedema - breakdown of the lymphatic's where transport capacity fails Presently diagnosed when patients can already have irreversible changes Painful lifelong conditi
Slide 7: Lymphedema Incidence Rates
Lymphedema Incidence Rates For personal use only Incidence of Lymphedema in Cancer Survivors • US breast cancer incidence – 240,000 cases/year • US Breast cancer survivors – 2.4 2 4 million • US pelvic cancer incidence – >450,000 cases/year • Women’s cancers, prostate, testicular, colon See referenc
Slide 8: Our Solution - Early Detection, Early Intervention
Our Solution -Early Detection, Early Intervention e e o For personal use only ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
Slide 9: Early Diagnosis and Treatment Results in Better Outcomes
Early Diagnosis and Treatment Results in Better Outcomes For personal use only 5 year prospective NIH study Conducted at National Naval Med Center NIH and d Navy N IRB oversight i ht Utilized a standardize metric for assessment of total arm volume not BIS • Breast cancer patients all pre-ope
Slide 10: ImpediMed Enables the New Clinical Paradigm
ImpediMed Enables the New Clinical Paradigm For personal use only High risk patient – homecare - therapist Surgeon Surgeon / L-Dex XCA baselines patient Oncologist |__|__|__|__|__|__|__|__|__|__|__| misc. code risk assessment $500 - $ $ $1000 Device misc. code consumables of $150-$300 per year Cance
Slide 11: Positive Reimbursement Environment
Positive Reimbursement Environment For personal use only Women’s Health and Cancer Rights g Act of 1998 requires q coverage g of lymphedema care (HR 4328 Public Law 105-277) Similar laws in 22 states Patient Advocacy Foundation (PAF) Providing reimbursement hotline support Currently surgeo
Slide 12: Positive Reimbursement Environment
Positive Reimbursement Environment For personal use only Requirements for category 1 code – technology specific BIS Need an FDA clearance for a BIS device (completed) Need to show it is billed on a miscellaneous code and that no other code is available (completed) Need 5 years of US peer rev
Slide 13: Bioimpedance Spectroscopy (BIS)
Bioimpedance Spectroscopy (BIS) For personal use only BIS technology directly measures the extracellular fluid At low frequency At high frequency Cell membrane Intercellular fluid Extracellular fluid ImpediMed’s BIS Technique 10 years of peer reviewed science on earlier detection Passes low-freq
Slide 14: Lymphedema - Current Detection Methods and Limitations
Lymphedema – Current Detection Methods and Limitations For personal use only Current detection methods Limitations May not detect until Tape measure lymphedema is irreversible Non-FDA approved Measures onlyy total volume change Archimedes method – water displacement j Subjective, non-standard me
Slide 15: BIS is Superior to All Other Detection Methods
BIS is Superior to All Other Detection Methods For personal use only Assessment ss ss and d Monitoring o o g Tools oo s Symptom Bioimpedance Archimedes Tape measure Perometer assessment Sensitivity Specificity Quantification Ease of use Time to measure Portability Evidence based YES NO YES YES YES
Slide 16: Commercial & Regulatory Status
Commercial & Regulatory Status For personal use only L-Dex U400 Single channel BIS device FDA cleared October 2008 Clinical assessment for uni- lateral lymphedema of the arm Uni-Leg submission mid CY2009 Over 10 yyears of p peer reviewed science built on BIS L-Dex UB500 Multiple channel
Slide 17: Business Model
Business Model For personal use only L-Dex U400 Place L-Dex devices in surgeons office free of charge Price per test of US$25 - $45 If a surgeon enrolls 8 new patients per month and is testing patients quarterly over the first two years, the placement will build to a monthly test volume of 64
Slide 18: Intellectual Property
Intellectual Property For personal use only Strong Patent Portfolio 12 patent families Filed internationallyy Covers BIS technology and consumable approach Key Trademarks Key brands and initiatives trademarked L-Dex Know your LL-Dex Dex ImpediMed Ltd - Surviving Cancer Without Compro
Slide 19: Focused Launch Strategy
Focused Launch Strategy For personal use only Physicians – initially targeting 5000 specialist breast surgeons Building the sales force from 4 reps to 40 reps Increase technical/training staff ASBS sponsored d registry Patients Enrollment p program g – all breast cancer p patients offere
Slide 20: ImpediMed's Technology Benefits all Parties
ImpediMed’s p Technology gy Benefits all Parties For personal use only Physicians – haven haven’tt had a realistic option previously – now have a reliable, easy to use predictive tool; profitable for their practices Patients – common fear given incidence/unsightliness, ability to have some contr
Slide 21: Operations
Operations For personal use only US facilities f iliti - San S Di Diego US operations/headquarters ti /h d t 15 employees 7 employees presently in sales, marketing Australian facilities- Brisbane 10 employees (R&D, accounts, ROW S&M etc.) M Manufacturing f t i willill be b split lit betw
Slide 22: Recent Financials
Recent Financials For personal use only As reported in Australian Dollars ($000) $K AU 2H 2008 USD (0.65) Revenue 1567 1 018 1,018 Profit from continuing opns (7,750) (5,037) EBITDA (7,417) (4,821) Current assets 7,685 4,995 Current liabilities (2,151) (1,398) Debt 0 0 •Average US$ exchange 0.909:1
Slide 23: Ownership Profile
Ownership Profile For personal use only % of Ownership p Public Funds ORBIS 14.8% Macquarie 6.1% Other institutional investors 9 0% 9.0% Venture Capital Starfish Ventures 26.9% Versant Ventures 5.7% Management 10.1% Shares outstanding 90.2m, options outstanding 17.9m WAEP 78 cents ImpediMed Ltd - Su
Slide 24: Investment Highlights
Investment Highlights For personal use only Lymphedema y p represents p a large g & underserved market Multi-hundred million dollar annual consumables market opportunity ImpediMed p has the first cleared technology gy to enable pre-emptive p p care Proven prevention of lymphedema progression
Slide 25: Thank you
For personal use only ImpediMed Thank you ImpediMed, Inc: 858.412.0200 info@impedimed.com www.impedimed.com www.L-Dex.com ASX:IPD ImpediMed Ltd - Surviving Cancer Without Compromising Lifestyle
Slide 26: Reference Information
Reference Information For personal use only 1. Warren A, Brorson H, Borud L, and Slavin S, Lymphedema: A Comprehensive Review, Annals of Plastic Surgery • Volume 59, Number 4, 2007 2. Francis 2 F i WP, WP AbAbghari h i P, P Du D W, W Rymal R l C, C Suna S M, M Kosir K i MA. MA Improving I i surgical
Slide 27: Reference Information (Cont)
Reference Information (Cont) For personal use only 11. Armer JM, Stewart BR. A comparison of four diagnostic criteria for lymphedema in a post-breast cancer population. Lymphat Res Biol 2005;3(4):208-17. ; ( ) Available from http://www.ncbi..nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=